Label: BLUZEN HAND SANITIZER WINTERMINT- ethyl alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 10, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses ? hand sanitizer to help reduce bacteria on skin

  • Warnings

    Flammable, keep away from fire/flame

    For external use only

    When using this product ? do not get into eyes. In case of contact, rinse eyes thoroughly with water

    ? do not inhale or ingest

    Stop use and ask a doctor if irritation and redness develop

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ? wet hands thoroughly with product and allow to dry without wiping

    ? supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    ? Store below 104°F (40°C)

  • Inactive ingredients

    water, aloe barbadensis leaf juice, glycerin, fragrance

  • QUESTIONS

    Questions? 1-800-777-1603

  • SPL UNCLASSIFIED SECTION

    MOISTURIZING FORMULA WITH ALOE VERA

    KILLS 99.9% OF GERMS

    SULFATE FREE PARABEN FREE VEGAN, CRUELTY FREE

    MADE IN THE USA

    Distributed by: Remcoda, LLC, New York, NY, 10018

    SHOPBLUZEN.COM

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    BLUZEN HAND SANITIZER WINTERMINT 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79200-607
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79200-607-1660 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/10/2020
    Labeler - Remcoda, Llc (117130169)
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